Uremic pruritus. Pruritus, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Mirtazapine tablets 7.5 mg (half a 15 mg tablet) in the first two nights and 15 mg (a whole tablet) from the third night at bedtime, along with hydroxyzine placebo
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age older than 18 years Hemodialysis for at least 3 months and having itch despite the adequacy of hemodialysis (Kt/V > 1.2) 5D-itch score more than 5 PSQI score equal and above 5
Exclusion criteria
Exclusion criteria: Anemia ( Hemoglobin less than 7 g/dL) Hyperparathyroidism ( iPTH > 600 ) Phosphorus level higher than 6 mg/dL and calcium higher than 10.5 mg/dL, or calcium multiplied by phosphorus higher than 60 Chronic skin diseases with itching which not related to uremia caused by kidney failure, such as psoriasis, dermatitis, and lichen planus. Chronic liver failure or high bilirubin level (1.5 times higher than the upper limit of normal) , and ALT, AST more than 5 times higher than the upper limit of normal. Untreated hypothyroidism Patients with psychiatric disorders, such as bipolar disorder, mental retardation, cognitive-functional disorder, or use of any psychotropic medication during the past month. History of suicide or patients with suicidal ideation Inability to receive oral medication Use of corticosteroids and opium Pregnancy and lactation History of allergy to mirtazapine Receiving medications that used for sleep disorders treatment within 1 month before entering the study (such as tricyclic antidepressants, atypical antidepressants, benzodiazepines, antihistamines, anticholinergics, and barbiturates) No interest to participate in the study or continue to treatment Any complications leading to intolerance and discontinuation of treatment with studied drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of itch Intensity using 5D-itch criteria. Timepoint: Baseline and the end of second, third and fourth weeks of starting the drug. Method of measurement: 5D-itch checklist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality changes based on the PSQI criterion. Timepoint: Baseline and the end of second, third and fourth weeks of starting the drug. Method of measurement: PSQI checklist.;Evaluation safety of the studied drugs. Timepoint: The end of the first, second and third weeks of starting the drug. Method of measurement: ASEC checklist. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNarjes Hendouei
Mazandaran University of Medical Sciences
Outcome results
None listed